The device was not returned for evaluation.The reported patient effect of dissection is listed in the xience xpedition everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was performed to treat a 90% stenosed, moderately tortuous, and heavily calcified de novo lesion in the left circumflex artery.Following pre-dilatation, a 2.5x23mm xience xpedition stent was deployed at 10 atmospheres (atms).After post-dilatation was performed with a 2.5x12mm non-compliant (nc) balloon at 16 atms, a distal edge dissection was noted.A 2.25x28mm xience xpedition stent was used to successfully cover the dissection.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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